To download the files, use the links below. Attachment(s): Download file SG1__Conformity_Assessment.pdf SG1__Essential_Principles_of_Safety_and_Performance_of_Medical_Devices.pdf SG1__Global_Medical_Device_Nomenclature_GMDN_System.pdf SG1__In_Vitro_Diagnostics_and_Global_Harmonization.pdf SG1__Principles_of_Medical_Device_Classification.pdf SG1__Roles_of_Standards_in_Assessment_of_Medical_Devices.pdf SG1__The_European_In_Vitro_Diagnostic_Directive,a_brochure.pdf SG2__Overview.pdf SG2__Post_Market_Vigilance_and_Surveillance.pdf SG2__TGA_Guidlines___Post_Market_Activities,_Guidance_No._11.pdf SG3__An_Introduction_to_Design_Verification_and_Validation.pdf SG3__Guidance_Documents.pdf SG3__Implementation_of_Risk_Management_Principles__Activities_within_a_Quality_Management_System.pdf SG3__Introduction_to_SG3.pdf SG3__ISO_13485_2000_An_Overview.pdf SG3__Process_Validation_Guidance.pdf SG3__Quality_Management_Systems_History_and_Evolution.pdf SG3__Session_Overview.pdf SG4__Auditing,_Session_Overview.pdf SG4__Auditing.pdf SG5__Clinical_Evidence_An_Overview.pdf Work_Group_A__Presentation.pdf Work_Group_B__Presentation.pdf Work_Group_C__Presentation.pdf Work_Group_D__Presentation.pdf
